Patients with neurodegenerative disease (especially, Parkinson'
Conditions
Interventions
2 months of voluntary exercise training and guidance using a remote rehabilitation system
Sponsors
Kawasaki Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have given written consent to participate in the research 2. 40 years of age or older 3a. For patients with Parkinson's disease, those diagnosed with probable PD or clinically established PD according to MDS criteria and HY stage 2-4 at the time of enrolment. 3b. For patients with mild dementia, those with MMSE less than 26 and greater than 17 and independent in activities of daily living except bathing. Background disease will be classified according to the revised NIA/AA diagnostic criteria (Alzheimer's disease) and the clinical diagnostic criteria for the prodromal DLB study (dementia with Lewy bodies), and those who are difficult to classify according to both will be classified as MCI unclassifiable (MCI-Dz). 3c. For patients with Parkinson's disease and dementia in the prodromal phase, those who meet some of the diagnostic biomarkers and diagnostic criteria for each disease listed above and are expected to develop the disease in the future. 4. Patients who have the cooperation of a caregiver 5. Patients who are able to walk a stable 10m with the use of assistive devices such as prostheses and walking sticks. 6. Patients who have been taking a fixed dose of antiparkinsonian or antidementia medication for at least two months prior to enrolment 7. Patients who be able to understand verbal instructions and perform tasks adequately
Exclusion criteria
Exclusion criteria: 1. Patients with severe cognitive impairment (<16 points on MMSE) 2. Patients with unstable general condition, including vital signs 3. Patients with severe visual impairment (corrected binocular vision below 0.05). 4. Patients who are pregnant, lactating or may become pregnant. 5. Patients with pre-existing or concomitant clinically relevant neuropsychiatric disorders (e.g. patients requiring adjustment of antipsychotic medication) 6. Patients who have participated in other motor function intervention studies within 6 months prior to enrolment 7. Patients who are difficult to assess at each visit due to unpredictable wearing-off or On-off symptom. 8. Patients with osteoarticular complications such as lumbar spinal stenosis or back pain that affect motor assessment 9. Patients who are deemed by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective satisfaction scale | — |
Secondary
| Measure | Time frame |
|---|---|
| All adverse events. System Usability Scale (SUS), exercise adherence (number of participants achieving acceptable adherence (>60%) and ideal adherence (>80%)), daily physical activity (physical activity, moderate- and high-intensity physical activity), balance and gait assessment (10 m - walking speed, Mini- BESTest, 3m-TUG test), change in upper limb function assessment (box and block test), change in motor features of Parkinson's disease (MDS-UPDRS, FOGQ), change in quality of life assessment (WHO-QOL, PDQ8), and change in functional/ structural MRI at the 2-month and 4-month visits compared with baseline. | — |
Countries
Japan
Contacts
Public ContactMihara Masahito
Kawasaki Medical School Hospital Department of neurology
Outcome results
None listed